Accelerating development of RP501 first-line therapy for dry eye disease

STOCKHOLM, Oct. 25, 2021 /PRNewswire/ -- Redwood Pharma announces today a strategic move to accelerate development of RP501, the company's IntelliGel-based topical first-line therapy for dry eye disease. While RP101 remains a clinically tested and unique candidate drug for post-menopausal women, the company will strengthen its focus on RP501 which has the potential of generating revenues in the near term for the company.

RP501 - a differentiated therapy addressing a large market

RP501 has significant therapeutic  and commercial as a next-generation first-line therapy to treat the majority of DED sufferer, including males and females of all ages. The global market is valued at US$2.3 billion in 2019 and expected to grow to US$2.9 billion by 2030 (Source: Transparency Market Research 2020). Today, these patients turn first to artificial tears (saline eye drops) to provide temporary relief.  Regular eye drops are quickly cleared from the front of the eye and need frequent reapplication, creating a need for products that stay longer on the eye and reduce the number of drops to provide daily relief.

RP501 (IntelliGel) was used as the vehicle (placebo control) in the RP101 Phase II clinical trial completed last year, and our data from the RP101 trial showed that twice daily administration of RP501 improved both symptoms and objective measures of DED, even in patients with severe disease. In this trial, RP501 demonstrated increased tear fluid production as measured by the Schirmer test. Likewise, it improved various symptoms including foreign body sensation and dryness. RP501, as an easy-to-apply alternative to artificial tears providing long-lasting relief with fewer instillations per day, may thus offer a convenient and differentiated solution to over 340 million people worldwide suffering from DED.

Next steps

The Redwood Pharma team has been working along with clinical and regulatory consultants to understand the regulatory pathways and identify and initiate activities to fill information gaps for regulatory approvals in Europe and the United States. The company has already successfully completed a laboratory test demonstrating compatibility of RP501 (IntelliGel) with commercial contact lenses with positive results. Based upon these results, Redwood has now decided to accelerate the pace of development towards a commercial medical device. Key next steps in the development of RP501 include: